Configured for compounding hazardous formulations specified on the NIOSH hazardous drug list

USP Compounding Cleanrooms,USP Compounding Cleanrooms,USP Compounding Cleanrooms

Available ISO Ratings: ISO 5, ISO 6, ISO 7, ISO 8

Manufactured By: Terra Universal

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Select Product Options

Frame Material	Width	Depth	Height	Panel Material	ISO Class	Price	Usually Ships in
Powder-Coated Steel	10'	6'	8'	Polypropylene	ISO 5	$26,362	25-31 Days
Powder-Coated Steel	10'	10'	8'	Polypropylene	ISO 5	$30,838	25-31 Days
Powder-Coated Steel	12'	10'	8'	Polypropylene	ISO 5	$33,637	25-31 Days
Powder-Coated Steel	12'	12'	8'	Polypropylene	ISO 5	$36,097	25-31 Days
Powder-Coated Steel	16'	8'	8'	Polypropylene	ISO 5	$34,637	25-31 Days

Summary

Available ISO Ratings: ISO 5, ISO 6, ISO 7, ISO 8

Free-standing 304 steel structure with polypropylene panels meets the requirements of USP 800 for negative-pressure containment in hazardous-drug compounding

Includes exhaust plenum with flanges for connection to the customer-furnished ventilation system capable of drawing out air introduced by the fan/filter units

Standard layout features a negative-pressure Buffer room (ISO 7 or 5, depending on requirement) and a positive-pressure ISO 7 Anteroom

Environmental Control System (included) monitors fan/filter units via 3.5" color touchscreen interface for easy air balancing; includes pressure and temperature sensors

Exceeds USP cleanliness and aseptic requirements

Verify before you buy: Consultation services available to ensure evaluate compliance with USP, cGMP, DQSA and other regulations

Smooth, durable, chemical-resistant polymers ensure the wall panels hold up against frequent cleaning

Features available for logging and storing room pressures and temperature

Pressure sensor included in each room

Individual variable control over all Fan/Filter Units to achieve target flow and pressure levels

Clock-calendar control of energy-saving setback mode

Standard configurations are available at affordable prices, or specify custom sizes to fit unique facility requirements

Standard turnkey configurations include RSR HEPA fan/filter units, LED light panels, duplex outlets, ante-/buffer room panels and ceiling grid; installed on site

These compounding cleanrooms are designed to the requirements of USP 800 as published in USP 40-NF 35. However, because practice standards vary from state to state and depend on compounding operations, Terra recommends consultation with our compounding experts to evaluate suitability for your application

Specifications

Helena

• Marks & Listings: UL, ULC

Features and Benefits

Hardwall Cleanroom Chemical-Resistant Panels

Chemically resistant polypropylene, mounted in mirror-finish steel brakets

Viewing Window for Modular Cleanroom

Cleanroom viewing windows provide ambient light and offer full visibility of the workspace. Polycarbonate offers chemical resistance, plus the highest durability (250x the impact resistance of glass). Static-Dissipative PVC panels are also chemical resistant and dissipate static charge to prevent particles from clinging to the window.

Hardwall Cleanroom LED Lights and Fan Filter Units

LED Lights, Fan Filter Units

HEPA fan/filter units (FFUs) exceed ISO 7 requirements for compounding buffer room; energy-efficient LED lights minimize generated heat

Adjustable Exhaust Vents

Adjustable IsoVents help control internal pressure to meet ISO regulations and maintain cascading pressure differentials.

Hardwall Cleanroom Environmental Control System

Available Environmental Control System

Standard cleanroom comes with analog pressure gauge and on/off controls; optional touchscreen FFU controller monitors, controls and logs internal pressure, as well as displaying temperature and RH.

Negative-Pressure Buffer Room

Negative-pressure ISO 5 or 7 Buffer room contains hazardous substances to protect the external environment, in accord with USP-800 requirements.

Exhaust Containment Plenum

Containment design includes exhaust plenums that route air from vents inside the enclosure to floor- or ceiling-mount fans, protecting the external environment from hazardous materials inside the cleanroom.

Seismic Safe Cleanroom Design

Terra’s modular cleanrooms are designed with seismic safety in mind. Rigid steel frames and ceiling grids are designed with sufficient factors of safety to provide vertical and lateral strength recommended by professional engineers. Both hardwall and softwall designs can be installed to adhere to local seismic codes. Optional seismic and structural calculations can be drafted and stamped by a licensed PE to help meet municipal permitting requirements.

4,000 Worldwide Cleanrooms

Since 1976, Terra has designed and manufactured over 4,000 cleanrooms for companies at the leading edge of high technology

Manufacturer, Distributor and Service Provider

Terra is not just a product manufacturer, we provide a suite of services to help our customers navigate the complex process of ensuring their equipment is operational

Products Compliant With Your ISO Rating

Provide Terra with your desired ISO rating. We will tailor the product to meet your rating and certify it with the serial numbers appended to your invoice, to be included in your compliance package.

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